The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
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Humacyte’s Acellular Tissue Engineered Vessel, a bioengineered regenerative vessel, is currently in clinical trial phases as a universally implantable vascular conduit that is non-immunogenic and that resists infection after implantation. Designed to be ready off-the-shelf, the ATEV has the potential to save valuable time for surgeons who treat injured patients, and to improve outcomes and reduce complications. The ATEV has accumulated more than 1,200 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease.
The US Food and Drug Administration (FDA) accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the ATEV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The FDA’s BLA decision is targeted for August 10, 2024.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
For more information, visit www.Humacyte.com.
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This video was filmed by Humacyte and is being sponsored for distribution in association with Vascular News and CX Vascular. Biba Medical bears no responsibility for the assets used in the production of this video.
